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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

PlexPCR® SARS-CoV-2

Manufactured by SpeeDx, Australia - https://plexpcr.com/ 

Device identification number
2825
CE Marking
Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Microplate
Specimen
Nasal aspirate, Nasal swab, Nasopharyngeal swab, Throat swab
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
A.23.1, AT.1, B.1.1.7 (Alpha), B.1.351 (Beta), B.1.427 (Epsilon), B.1.429 (Epsilon), B.1.525 (Eta), B.1.526 (Iota), B.1.526.1, B.1.526.2, B.1.616, B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3, B.1.621 (Mu), C.36, C.37 (Lambda), P.1 (Gamma), P.2 (Zeta), P.3 (Theta)
Commercial Status
Commercialised
Last Update
2022-12-02 09:22:17 CET
Comments
https://plexpcr.com/products/respiratory-infections/plexpcr-sars-cov-2/
Assay Type
Nucleic acid-PCR
Method
RT-PCR

The database contains publicly available In Vitro Diagnostic Medical Devices for COVID-19 and it is being updated periodically. Please note that additional performance (as retrieved from manufacturers web pages) is provided only for devices commercially available with CE-IVD mark. Acknowledgements